CTRI/2025/10/096241尚未招募2 期
Comparison of Tumescent versus Conventional Dissection in raising flaps during Modified Radical Mastectomy - A Randomized Controlled Study
Maulana Azad Medical College and Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年10月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Amount of blood loss (in ml)
研究概览
简要总结
patients requiring mastectomy will be worked up and sorted in 2 groups- controls and cases and study will be performed.
This is to see if the tumescent solutions has any added benefits with regards to blood loss and flap health to the conventional mastectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •18-65 yrs women.
排除标准
- •prior breast surgery (except biopsy)/ recurrence immediate breast reconstruction previous radiotherapy allergy to lignocaine.
结局指标
主要结局
Amount of blood loss (in ml)
时间窗: baseline and day-0
次要结局
- operative time (in mins)(baseline)
- presence of any skin flap necrosis(baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13, 14 days)
- DURATION OF HOSPITAL STAY(NIL)
- POSTOPERATIVE PAIN(baseline, 1,2,3,4,5,6,7 days)
- SURGICAL SITE INFECTION INCLUDIMG INCISIONAL DEHISECENCE(baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14 days)
- SEROMA/HEMATOMA FORMATION(baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13, 14 days)
研究者
Dr C B Singh
Maulana Azad Medical College
研究点 (1)
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